H1 2017 Results - AstraZeneca€¦ · Q2 2017: First quarter since 2010 with ~$1bn in Product Sales...
Transcript of H1 2017 Results - AstraZeneca€¦ · Q2 2017: First quarter since 2010 with ~$1bn in Product Sales...
H1 2017 Results
Media Conference call and Webcast 09:00 BST 27 July 2017
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary
statement:
This document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other
things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although we believe our expectations are based on
reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause
actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of
preparation of this document and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by
using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ
materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of, or
limitations to, patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent protection; effects of patent litigation in respect of IP rights;
the impact of any delays in the manufacturing, distribution and sale of any of our products; the impact of any failure by third parties to supply materials or services; the
risk of failure of outsourcing; the risks associated with manufacturing biologics; the risk that R&D will not yield new products that achieve commercial success; the risk
of delay to new product launches; the risk that new products do not perform as we expect; the risk that strategic alliances and acquisitions, including licensing and
collaborations, will be unsuccessful; the risks from pressures resulting from generic competition; the impact of competition, price controls and price reductions; the
risks associated with developing our business in emerging markets; the risk of illegal trade in our products; the difficulties of obtaining and maintaining regulatory
approvals for products; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the risk of failure to
successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk of failure of critical processes affecting
business continuity; economic, regulatory and political pressures to limit or reduce the cost of our products; failure to achieve strategic priorities or to meet targets or
expectations; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; the risk of substantial product liability
claims; the risk of failure to adhere to applicable laws, rules and regulations; the risk of failure to adhere to applicable laws, rules and regulations relating to anti-
competitive behaviour; the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; taxation risks; exchange
rate fluctuations; the risk of an adverse impact of a sustained economic downturn; political and socio-economic conditions; the risk of environmental liabilities; the risk
of occupational health and safety liabilities; the risk associated with pensions liabilities; the impact of failing to attract and retain key personnel and to successfully
engage with our employees; the risk of misuse of social medial platforms and new technology; and the risk of failure of information technology and cybercrime. Nothing
in this presentation / webcast should be construed as a profit forecast.
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Forward-looking statements
Presenters
3
Participants
Pascal SoriotExecutive Director and
Chief Executive Officer
Mark MallonExecutive Vice President,
Global Products & Portfolio
Strategy, Global Medical
Affairs, Corporate Affairs
Jamie FreedmanExecutive Vice President and
Head, Oncology Business Unit
Marc DunoyerExecutive Director and
Chief Financial Officer
Sean BohenExecutive Vice President,
Global Medicines Development
and Chief Medical Officer
Joined by for Q&A
4
Agenda
Overview
Oncology
Pipeline and news flow
Closing and Q&A Antibody that blocks inhibitory signals
from the tumour to cells of the immune
system, resulting in enhanced anti-
tumour immunity
Business & financials
Total Revenue declined as anticipated, reflecting mainly the tail impact of Crestor’s and Seroquel XR’s US
loss of exclusivity
Sales from Growth Platforms increased
• Emerging Markets: Up 6%, some impact from economic conditions in LatAm/MEA1
– China: Up 8%; Tagrisso off to a strong start
• Respiratory: Continued to be impacted by US Symbicort
• New CVMD2: Supported by Brilinta (+28%) and Farxiga (+22%)
• Japan: Up 6%, supported by lapping of price cuts and strength of Tagrisso
• New Oncology: Boosted by Tagrisso ($403m)
EPS growth underpinned by cost management and Other Operating Income
2017 guidance reiterated
H1 2017: In line with expectations
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Highlights
1. LatAm/MEA = Latin America and Middle-East & Africa.2. CVMD = Cardiovascular & Metabolic Diseases.
Growth at Constant Exchange Rates (CER) and for H1 2017, unless otherwise stated. Guidance at CER.
Pipeline
Oncology • Imfinzi bladder cancer Approval (US)
lung cancer Stage III Phase III PACIFIC: Met PFS1 primary endpoint
lung cancer 1L Phase III MYSTIC: Did not meet PFS primary endpoint
• Tagrisso lung cancer 1L Phase III FLAURA: Met primary endpoint
• Faslodex breast cancer 1L Approval (EU, JP)
• Lynparza ovarian cancer 2L Regulatory submission acceptance (EU, JP)
Cardiovascular & • Bydureon type-2 diabetes CVOT2 Phase III EXSCEL: Met primary safety objec-
Metabolic Diseases tive; did not meet primary efficacy objective
Respiratory • Bevespi COPD Regulatory submission (EU)
• tralokinumab severe, uncontrolled Phase III STRATOS 1: Did not meet primary
asthma endpoint; results now inform STRATOS 2
Other • Kyntheum psoriasis Approval (EU; received by partner)
New scientist joiners • Jean-Charles Soria, SVP, Research and Early Development, from Gustave Roussy Cancer Centre
IO franchise • Geoffrey Kim, Head of Oncology Strategic Combinations, from US FDA
Pipeline news summary
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Highlights, continued
1. PFS = Progression-free survival.2. CVOT = Cardiovascular outcomes trial.
Status since the results announcement on 27 April 2017.
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
H1 2012 H1 2013 H1 2014 H1 2015 H1 2016 H1 2017
US patent losses
(Crestor/Nexlum/Seroquel)
Other out-of-patent medicines
(outside Emerging Markets)
Externalisation
Emerging Markets
(established medicines)
Respiratory
Oncology
New AstraZeneca emerging visibly from patent losses
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Total Revenue: An inflection point approaching
Absolute values at CER. Change at CER and for H1 2017, unless otherwise stated.
New CVMD
(Brilinta & Diabetes)
+4%
H1 2017
$m
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2017: Becoming a defining year
2012 2013 2014 2015 2016 2017E
benralizumab
Launches of new medicines
from main therapy areas
Some of the key news flow
opportunities in 2017
Imfinzi /
Imfinzi + treme
NSCLC1 1L
MYSTIC PFS
Imfinzi
bladder cancer
reg. decision
Tagrisso
NSCLC 1L
FLAURA
benralizumab
asthma
reg. decision
Lynparza
multiple cancers
data readouts
acalabrutinib
blood cancers
fast-to-market
opportunity
ZS-9
hyperkalaemia
reg. decision
1. NSCLC = Non-small cell lung cancer.
✓
✓
✓
✘
✓
PDUFA
Q4 2017
✓
Imfinzi
NSCLC Stage III
PACIFIC PFS
✓ ✓✘
Merck collaboration expands potential, in particular for IO combos
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Lynparza affirmed as the globally-leading PARP inhibitor
• Establishes Lynparza as the preferred PARP-
inhibitor backbone of future PD-1/PD-L1
combinations
• Accelerates Lynparza’s development with the
leading PD-1 inhibitor in clinical trials, Keytruda
• Financially-attractive total deal value of up to
$8.5bn
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Agenda
Overview
Oncology
Pipeline and news flow
Closing and Q&A Antibody that blocks inhibitory signals
from the tumour to cells of the immune
system, resulting in enhanced anti-
tumour immunity
Q2 2017: First quarter since 2010 with ~$1bn in Product Sales
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Oncology
• Total Oncology
• 20% growth and 19% of total Product Sales
• Faslodex (+16%) benefited from recent label
expansions into 1st-line use and combination
• New Oncology
• Commitment to six new medicines 2014-2020;
three already delivered:
• Tagrisso: Very strong uptake, particularly in Asia
• Imfinzi: Strategic launch May 2017
• Lynparza: Continued strong news flow; 2nd-line
ovarian and breast cancer
Oncology Product Sales
New medicines boosting growth
0
200
400
600
800
1,000
1,200
Q12014
Q22014
Q32014
Q42014
Q12015
Q22015
Q32015
Q42015
Q12016
Q22016
Q32016
Q42016
Q12017
Q22017
Other Oncology Zoladex Faslodex Iressa Lynparza Tagrisso Imfinzi
$m
Absolute values at CER.
Strong growth
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Tagrisso
• US: T790M1-mutation testing rate
holding back access to Tagrisso
• Progress being made on
improving testing and
education around
ctDNA/plasma retesting
• Europe: More reimbursements
secured
• Japan: Continued strong growth;
T790M testing rate >90%
• China: First launch in May
Continued global growth Global commercial execution 1st-line opportunity as seen
in EGFRm2 cohort from Phase I
60EGFRm patients who
received Tagrisso
in 1L setting
77%confirmed overall
objective response rate
19.3months of median PFS
0
50
100
150
200
250
Q1 2016
Q2 2016
Q3 2016
Q4 2016
Q1 2017
Q2 2017
US Europe EM Est. ROW
$m
2. EGFRm = Epidermal growth factor receptor mutation.Source: ELCC 2016, abstract LBA1_PR.Absolute values at actual exchange rates.
1. T790M = Mutation that results in an amino acid substitutionat position 790 in EGFR, from threonine (T) to methionine (M).
Strategic US launch in bladder cancer; preparing for lung cancer
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Imfinzi
• Met PFS primary endpoint based on interim analysis
- trial continues to assess OS1 primary endpoint,
anticipated in 2019 at the latest
• Regulatory submission anticipated in H2 2017
• ~100,000 Stage III patients in G7; about half have
unresectable tumours
• Two-three years ahead of competitors
Bladder cancer
US launchStage III unresectable NSCLC
PACIFIC trial
1. OS = Overall survival.Source: BrandImpact market research, May 2017, AstraZeneca epidemiology data. G7 countries include the US, Japan, Germany, the
UK, France, Italy and Canada.
8Weeks since launch
2nd
‘Share of Voice’ position
>35%‘Share of Voice’ share
2LSOLO-2 trial
Under regulatory
review4L (US)Study 19 trial
Approved
Breast cancerOLYMPIAD trial
Regulatory
submission H2 2017
Early breast cancerOLYMPIA trial
Data 2019+
Prostate cancerPROFOUND trial
Data 2019+
Pancreatic cancerPOLO trial
Data 2019
bevacizumab
(VEGF) comboPAOLA-1
Data 2019+1LSOLO-1 trial
Data H1 2018
cediranib (VEGFr)
comboData 2019
Imfinzi comboMEDIOLA
DDR combosWEE-1
ATM
ATR
AuraB Kinase
~ 14Potential launches
2017
2018
2019+
2016
1) Establish
leadership3) 2) Add VEGF(r)
combinations
4) New combinations
& New tumor types
2) Expand patient
segments
Global leader
Lynparza
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Establish as the preferred PARP-inhibitor backbone of future
PD-1/PD-L1 and DNA Damage Response (DDR) combinations
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Lynparza - Merck collaboration
Illustrative
Monotherapy
Combination with DDR
Combination with VEGF(r)
Combination with IOBRCAm
HRRm
Lynparza combinations
market opportunity
Expanding patient population
BRCAm HRRm Biomarker negative
Source: AstraZeneca epidemiology data.HRRm = Homologous recombination repair mutation.
Accelerates development with the leading PD-1 in clinical trials
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Lynparza - Merck collaboration
39%
13%
33%
11%
4%
Keytruda
Imfinzi
nivolumab
atezolizumab
avelumab
Ongoing trials for approved PD-1/L1 medicines
Source: Sanford C. Bernstein, LLC, 21 July 2017.
Combined more than half of all ongoing trials
Summary
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Lynparza - Merck collaboration
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Combines capabilities of two main oncology players✓
Establishes Lynparza as the preferred PARP-inhibitor
backbone of future PD-1/PD-L1 combinations✓
Accelerates Lynparza’s development with the
leading PD-1 inhibitor in clinical trials, Keytruda
Maximises potential number of treatment options
available✓
✓
Total payments to AstraZeneca of up to $8.5bn✓
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Agenda
Overview
Oncology
Pipeline and news flow
Closing and Q&A Antibody that blocks inhibitory signals
from the tumour to cells of the immune
system, resulting in enhanced anti-
tumour immunity
• Bevespi - COPD: Regulatory
submission acceptance (EU)
• tralokinumab - severe,
uncontrolled asthma: Did not meet
primary endpoint in first Phase III
trial, STRATOS 1
• Kyntheum (brodalumab) -
psoriasis: Approval (EU, received
by partner)
• Bydureon - type-2 diabetes: Met
primary safety objective in CVOT;
did not meet primary efficacy
objective
• Imfinzi
- bladder cancer: Approval (US)
- lung cancer:
Stage III (PACIFIC): Met PFS primary
endpoint
1L (MYSTIC): Did not meet PFS primary
endpoint for combo with treme
• Tagrisso - lung cancer 1L (FLAURA):
Met primary endpoint
• Faslodex - breast cancer 1L: Approval
(EU, JP)
• Lynparza - ovarian cancer 2L:
Regulatory submission acceptance (EU,
JP)
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Q2 2017 late-stage pipeline update
RespiratoryCardiovascular &
Metabolic DiseasesOncology
Status since the prior results announcement on 27 April 2017.
Other
Patients with EGFR-
mutated tumours
~15-20% of patients,
but double in Asia
Iressa
EGFRm
Tagrisso
ADAURA (2021/2022)
Tagrisso
FLAURA
Tagrisso
T790M
Patients with no EGFR-
or ALK-mutated tumours
~75-80% of patients
PEARL
(2020)
NEPTUNE
(H2 2018)
= Imfinzi + treme ADJUVANT
(2020)
PACIFIC
(2019 final OS)= Imfinzi
Stage/progression
of disease
Stage Ib-IIIa Stage III 1st line 2nd/3rd line
Stage I-III (early / non-metastatic) Stage IV (metastatic)
Overview of approved medicines and ongoing Phase III trials
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AstraZeneca in non-small cell lung cancer (NSCLC)
✓
✓✓
POSEIDON CTx
(2019)
MYSTIC
(H1 2018 final OS)
ARCTIC
(H2 2017)
( ) = First/next data anticipated.Source: AstraZeneca epidemiology data.
✓
• Did not meet PFS endpoints
for Imfinzi and treme
combination or Imfinzi mono-
therapy
• Trial continues to assess OS pri-
mary endpoints for Imfinzi and the
Imfinzi + treme combination
• Final OS data expected H1 2018
• Met the primary endpoint showing
a statistically-significant and
clinically-meaningful improvement
in PFS
• OS is a secondary endpoint; trial
will be followed to greater maturity
• Regulatory submission H2 2017
Stage IV metastatic (~1/2 of NSCLC)
• Met a primary endpoint of
statistically-significant and
clinically-meaningful improvement
in PFS based on interim analysis
• Trial continues to assess OS
primary endpoint anticipated in
2019 at the latest
• Regulatory submission H2 2017
Imfinzi and Tagrisso continue to inform
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NSCLC: Three major news items
FLAURA trial15-20% EGFR mutated (double in Asia)
MYSTIC trial80-85% EGFR wild type
Stage III unresectable (10-15% of NSCLC)
PACIFIC trial
Increased presence in lung cancer across stages and key segments
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Imfinzi: MYSTIC trial has more data to come
Illustrative. Trial is event-driven.
2017 H1 2018
Primary endpoints
Imfinzi + treme combo
PFS in ‘expressers’ PFS final analysis
Imfinzi + treme combo
OS in ‘expressers’ OS final analysis
Imfinzi
OS in ‘expressers’ OS final analysis
OS interim analyses
Mid-2017
OS interim analyses
✘
Broad development programme in NSCLC patients
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Imfinzi: Overview of ongoing Phase III trials
ADJUVANT PACIFIC MYSTIC NEPTUNE PEARL POSEIDON ARCTIC
Trial design
Stage Ib-IIIa
Randomised,
controlled
Imfinzi vs
placebo
Stage III
unresectable
Randomised,
controlled
Imfinzi vs
placebo
Stage IV / 1L
EGFR/ALK wt
Non-sq / sq2
Randomised,
controlled
Imfinzi,
Imfinzi + treme
vs SoC
Stage IV / 1L
EGFR/ALK wt
Non-sq / sq
Randomised,
controlled
Imfinzi + treme
vs SoC
Stage IV / 1L
EGFR/ALK wt
Non-sq / sq
PD-L1 expr.
Randomised,
controlled
Imfinzi vs
SoC
Stage IV / 1L
EGFR/ALK wt
Non-sq / sq
Randomised,
controlled
Imfinzi + SoC,
Imfinzi + treme
+ SoC vs SoC
Stage IV / 3L
EGFR/ALK wt
Non-sq / sq
PD-L1 low
Randomised,
controlled
Imfinzi, treme,
Imfinzi + treme
vs SoC
Primary
endpoint(s)DFS1 PFS
OS
PFS
OSOS
PFS
OSPFS
PFS
OS
Data readout 2020
PFS
2019
(final OS)
PFS
H1 2018
(final OS)
H2 2018 2020 2019 H2 2017
Recruitment
statusOngoing Fully recruited Fully recruited Fully recruited Ongoing Ongoing Fully recruited
✔
1. DFS = Disease-free survival.2. Non-sq / sq = Non-squamous / squamous (histology).
✘
= Imfinzi
✔ = fully recruited= Imfinzi +/- treme
Head & neck cancer,
bladder cancer (UC1)
EAGLE
2L H&N
KESTREL
1L H&N
DANUBE
1L bladder
Lung cancer
(NSCLC)
POSEIDON
1L IO-IO-CTx triple
PEARL
1L (Asia)
ARCTIC
3L PD-L1 low/neg.
MYSTIC
1L (final OS)
NEPTUNE
1L (final OS)
ADJUVANT
Adjuvant
H2 2017 H1 2018 H2 2018 2018+
Potential leadership in IO & IO-IO combinations across multiple cancer types
Ongoing Phase III trials across tumour types
24
Imfinzi: Expected upcoming news flow
1. Urothelial carcinoma.2. Global trial excluding China.
✔ ✔ ✔
✔ ✔2
Upcoming key late-stage news events
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Oncology: News flow to intensify
Major Oncology milestones over the 2017-2018 timeframe
Lynparza
ovarian cancer 2L
reg. decision (US)
Imfinzi +/- treme
lung cancer 1L
Phase III MYSTIC
(final OS)
Imfinzi +/- treme
head/neck cancer 1L
Phase III KESTREL
Imfinzi +/- treme
lung cancer 3L
Phase III ARCTIC
acalabrutinib
blood cancer
reg. submission (US)1
Faslodex
breast cancer 1L
reg. decision (US)
Lynparza
breast cancer
reg. submissions
Imfinzi
lung cancer Stage III
reg. submission
Lynparza
ovarian cancer 1L
Phase III
Imfinzi + treme
lung cancer 1L
Phase III NEPTUNE
moxetumomab
leukaemia
Phase III
selumetinib
thyroid cancer
Phase III
Imfinzi +/- treme
bladder cancer
Phase III DANUBE
Imfinzi +/- treme
head/neck cancer 2L
Phase III EAGLE
1. Potential fast-to-market opportunity ahead of randomised, controlled trials.Timeline based on H1 2017 Results forthcoming major news flow; the exact location of each box is approximate.
= Relatively bigger news item = Relatively smaller news item
- August -
• Brilinta - CV disease
New insights from PEGASUS-TIMI
54 trial in high-risk PMI2 patients
• Farxiga - T2D
CVD-REAL real-world evidence
study; additional findings/sub-group
analyses
• ZS-9 - hyperkalaemia
Clinical outcomes and healthcare
resource use in CHF3 patients
- June -
• Farxiga - Type-2 diabetes (T2D)
CVD-REAL real-world evidence
study; additional findings/sub-group
analyses
• Farxiga + Bydureon - T2D
DURATION-8 52 weeks and
subgroup data
• Bydureon + insulin - T2D
DURATION-7: Reduction in HbA1c1,
weight, fasting plasma glucose and
post-prandial glucose
- September -
• Farxiga - Type-1 diabetes
Phase III DEPICT-1 trial primary
results
• Bydureon - T2D
Full data from the Phase IIIb/IV
EXSCEL CVOT
• ZS-9 - hyperkalaemia
Clinical and resource burden of
hyperkalaemia in diabetic population
Jointly addressing metabolic / cardio / renal risks
26
CVMD: Highlights from medical meetings
1. HbA1c = Glycated haemoglobin A1c.2. PMI = Perioperative myocardial infarction.
3. CHF = Chronic heart failure.
Unlocking and realising the potential of new medicines
27
Late-stage pipeline news flow in 2017 and 2018
H2 2017 H1 2018 H2 2018
Regulatory decision Faslodex - breast cancer 1L (US)
Lynparza - ovarian cancer 2L (US)
Bydureon - autoinjector (US)
benralizumab - severe, uncontrolled asthma (US)
Lynparza - ovarian cancer 2L (EU, JP)
benralizumab - severe, uncontrolled asthma (EU,
JP)
Bevespi - COPD (EU)
Regulatory submission Lynparza - breast cancer
Tagrisso - lung cancer 1L
Imfinzi - lung cancer (PACIFIC)
Imfinzi +/- treme - lung cancer (ARCTIC)
acalabrutinib - blood cancer (US)1
Bydureon - autoinjector (EU)
Lynparza - ovarian cancer 1L
moxetumomab - leukaemia
selumetinib - thyroid cancer
Bevespi - COPD (JP)
Duaklir - COPD (US)
tralokinumab - severe, uncontrolled asthma
Imfinzi + treme - lung cancer (NEPTUNE)
Imfinzi +/- treme
- lung cancer (MYSTIC)
- head & neck cancer (KESTREL, EAGLE)
- bladder cancer (DANUBE)
roxadustat - anaemia (US)
benralizumab - COPD
PT010 - COPD (JP)
Key Phase III data
readouts
Imfinzi +/- treme - lung cancer (ARCTIC)
moxetumomab - leukaemia
tralokinumab - severe, uncontrolled asthma
Lynparza - ovarian cancer 1L
Imfinzi +/- treme
- lung cancer (MYSTIC) (final OS)
- head & neck cancer (KESTREL, EAGLE)
selumetinib - thyroid cancer
PT010 - COPD
Imfinzi + treme - lung cancer (NEPTUNE)
Imfinzi +/- treme - bladder cancer (DANUBE)
benralizumab - COPD
anifrolumab - lupus
1. Potential fast-to-market opportunity ahead of randomised, controlled trials.
28
Agenda
Overview
Oncology
Pipeline and news flow
Closing and Q&A Antibody that blocks inhibitory signals
from the tumour to cells of the immune
system, resulting in enhanced anti-
tumour immunity
• H1 2017 in line with expectations
– Financials on track
– Guidance reiterated
– Continued busy pipeline news flow
• 12 new potential medicines in Phase III/under registration
• Oncology progressing
– Tagrisso, Lynparza ahead of expectations
– Imfinzi: PACIFIC positive; MYSTIC waiting for OS
• Continued busy pipeline news flow over next nine months
New AstraZeneca steadily emerging during 2017
29
Pipeline-driven transformation continues
30
Q&A
H1 2017 Results
Conference call and webcast for investors and analysts 27 July 2017